Adverse Effect of Contact Lens Solution Clinical Trial
Official title:
Product Performance of Bausch & Lomb Multi-Purpose Solution Compared to Alcon Opti-Free Replenish Multi-Purpose Solution When Used With Silicone Hydrogel Contact Lenses Worn on a Daily Wear Basis
| Verified date | December 2011 |
| Source | Bausch & Lomb Incorporated |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution
| Status | Completed |
| Enrollment | 361 |
| Est. completion date | April 2008 |
| Est. primary completion date | March 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects are adapted wearers of silicone hydrogel contact lenses - VA correctable to 0.3 LogMAR or better (driving vision) - Clear central cornea - Subject uses a lens care system on a regular basis Exclusion Criteria: - Systemic disease affecting ocular health - Using systemic or topical medications - wear a monovision, multifocal or toric contact lenses - Any grade 2 or greater slit lamp findings |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Malaysia | Laser Focus Sdn Bhd, Vision Correction Centre | Jalan Kuning, Tamn Pelangi | Johor Bahru |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch & Lomb Incorporated |
Malaysia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Subjective Assessment of Comfort and Cleanliness | Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating. | 7 days | No |
| Secondary | Symptoms and Complaints | Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score. | 2 weeks | No |
| Secondary | Graded Slit Lamp Findings > Grade 2 | Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2. | 2 week follow-up visit | No |